Potassium aluminium silicate amorphous glass fibres

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019/2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide

EC Number:

931-219-8

Molecular formula:

SinO(3n-1)2(n-1) polymeric anions ionically bonded to Al3+ and K2+ cations

IUPAC Name:

silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide

Test material form:

solid - liquid: suspension

Remarks:

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

Species:

human

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Reconstructed Human Cornea-like Epithelium

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- 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:

2

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

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Mean Tissue Viability (%)

Value:

ca. 97.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

substance is non-irritating