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Diss Factsheets

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:
06.03.2018 to 16.07.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
[2,2,6,6-tetramethyl-4-(trimethylazaniumyl)piperidin-1-yl]oxidanyl chloride
EC Number:
814-375-0
Cas Number:
67036-09-3
Molecular formula:
C12H26N2OCl
IUPAC Name:
[2,2,6,6-tetramethyl-4-(trimethylazaniumyl)piperidin-1-yl]oxidanyl chloride
Test material form:
solid

Test animals / tissue source

Species:
human
Details on test animals or tissues and environmental conditions:
The test was carried out with the EpiOcular™ reconstructed human cornea-line epithelium (RhCE) model (MatTek). The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified, highly differentiated squamous epithelium morphologically similar to that found in a human cornea. The EpiOcular™ RhCE tissue construct consists of at least 3 viable layers of cells and a non-keratinized surface, showing a cornea-like structure analogous to that found in vivo.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50 mg of test item
Duration of treatment / exposure:
6 h
Duration of post- treatment incubation (in vitro):
18 h

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: mean relative tissue viability [%]
Run / experiment:
1
Value:
13.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: mean relative tissue viability [%]
Run / experiment:
2
Value:
8.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

  1. Name

    Negative Control

    Positive Control

    Test item

    Tissue

    1

    2

    1

    2

    1

    2


    OD570values

    1.665

    1.474

    0.423

    0.393

    0.256

    0.180

    1.645

    1.481

    0.421

    0.392

    0.255

    0.179

    OD570values (blank-corrected)

    1.620

    1.429

    0.378

    0.348

    0.211

    0.135

    1.600

    1.437

    0.377

    0.347

    0.210

    0.134

    mean of the duplicates

    1.610

    1.433

    0.377

    0.347

    0.210

    0.135

    mean OD

    1.521*

    0.362

    0.173

    mean sd OD

    0.125

    0.021

    0.053

    tissue viability [%]

    105.8

    94.2

    24.8

    22.8

    13.8

    8.9

    relative tissue viability difference[%]***


    11.6


    2.0


    5.0

    mean tissue viability [%]

    100.0

    23.8**

    11.3

* Corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability

** Mean relative tissue viability of the positive control is < 50%

*** Relative tissue viability difference of replicate tissues is < 20%

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In this study under the given conditions the test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (11.3%). The test item is classified as “irritant“ in accordance with UN GHS “Category 1” or “Category 2”. Based on this test alone, a decision on classification into one of the 2 categories is not possible.