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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

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

Constituent 1
Reference substance name:
oxo[(oxoalumanyl)oxy]alumane; silanedione
EC Number:
604-314-4
Cas Number:
142844-00-6
Molecular formula:
amorphous glass Si(n)O(3n+1) polymeric anions bonded to Zr and Al(3+)
IUPAC Name:
oxo[(oxoalumanyl)oxy]alumane; silanedione
Test material form:
solid: fibres
Details on test material:
- Name of test material (as cited in study report): Refractory Ceramic Fibre (RCF)
- Substance type: Fibre
- Physical state: Solid
- Analytical purity: assumed to be 100%
- Impurities (identity and concentrations): none
- Lot/batch No.: BG-19-X99-6484
- Stability under test conditions: Indefinitely stable
- Storage condition of test material: room temperature, dark

Test animals / tissue source

Species:
human
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Reconstructed human like epithelium

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50mg solid
Duration of treatment / exposure:
6hours+/- 15 mins
Duration of post- treatment incubation (in vitro):
18hours+/- 15 mins
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:
expected
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Ocular irritation prediction

According to OECD guidelines and GHS classification, an irritant is predicted if the mean relative tissue viability of two individual tisues exposed to the test substance is <=60% of the mean viability of the negative controls.

In vitro result

GHS Classification

Mean tissue viability less than or equal to 60%

Category 1 or 2

Mean tissue viability greater than 60%

No category

 

The summarised results and irritation classification are as follows:

Test and Control Article identity

Tissue Viability

Irritancy classification

GHS Classification

Mean

Diff.

Refractory ceramic fibre (RCF) - Aluminosilicate wool

105.4%

5.38%

Non-irritant

No Category

Tissue Culture water (negative control)

100.0%

2.67%

Non-irritant

No Category

Methyl acetate (positive control)

36.0%

6.03%

Irritant

Category 1 or 2

 

Diff = difference between the tissues

Applicant's summary and conclusion

Interpretation of results:
other: Classed as non irritating
Conclusions:
substance is confirmed to be not irritatiing and as such is not classified as an irritant
Executive summary:

Substance was confirmed as non irritating